FDA OKs Esteya system for skin cancer treatment

The Food and Drug Administration has granted 510(k) clearance to Nucletron for Esteya, an electronic brachytherapy system for high-precision skin cancer treatment.

The Esteya system, manufactured by Nucletron, an arm of Stockholm-based Elekta, uses a small high-dose rate (HDR) X-ray source to apply radiation directly to the cancerous site, focusing therapeutic radiation on the disease target and minimizing radiation to surrounding tissues, according to a news release.

Electronic brachytherapy typically achieves a 95 percent cure rate treating skin lesions such as basal cell or squamous cell carcinoma, the company states.

“The interest in Esteya among radiation oncologists during the American Society for Radiation Oncology annual meeting ... in Atlanta was encouraging,” John Lapré, executive vice president, brachytherapy, for Elekta, said in the news release. “They appreciated the efficient work flow, easy patient set-up, and the short treatment delivery time. They also cited the accessibility of Esteya - due to its compact design and reduced shielding requirements - allowing treatment to occur virtually anywhere patients are seen within the clinic.”

The company says the first installations of Esteya in the United States are scheduled to occur in the next few months.